Common Variable ImmunodeficiencyPhase 2NCT05593588
Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency
A Phase 2 study testing Fisetin in people with Common Variable Immunodeficiency and Interstitial Lung Disease Due to Systemic Disease, run by Avni Joshi at 1 site in United States.
Trial summary
The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Variable Immunodeficiency, Interstitial Lung Disease Due to Systemic Disease
- What is being tested?
- Fisetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have received a diagnosis of CVID according to the international consensus document (ICON) at least 30 days before enrollment.
- Physician diagnosis of possible GLILD associated with CVID.
- IgA results.
- Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile. (A negative pregnancy test for women whose menopausal status is determined by self-reported absence of menstrual periods in the past 12 months will be required within 72 hours prior to randomization).
- Patient must be able and willing to comply with the requirements of this study protocol.
Who cannot join
- Unable or unwilling to give informed consent.
- Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial.
- Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization.
- WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.
- Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.
- Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
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- Patient currently hospitalized or under immediate consideration for hospitalization.
- Current use of tobacco products or as per clinical judgement.
- Current excessive caffeine intake (400 mg or more per day).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Senolytics as a Novel Treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)
The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo.
- Being tested
- Fisetin, Placebo
- Medical subject headings
- Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinDrug
20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29
PlaceboDrug
Looks exactly like the study drug, but it contains no active ingredient. Administered orally on days 0, 1, 28 and 29
| Study group | Role | What they receive |
|---|---|---|
| Fisetin Group | Experimental | Subjects will receive the supplement, Fisetin, for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29) Receives: Drug: Fisetin |
| Placebo Group | Placebo comparator | Subjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immunophenotyping of peripheral T lymphocytes
Measured by percentage of activated CD4+25+ T cells
Measured: Baseline, 6 months
Secondary outcomes (7)
Change in Forced Vital Capacity (FVC)
Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)
Measured: Baseline, 6 months
Change in radiologic imaging in subjects
Number of subjects to have a 10% improvement with the CT scoring system. Radiologist will score the CT scans at each time point and changes in score at each time point will be noted.
Measured: Baseline, 3 months, 6 months
Use of MRI imaging for assessment of GLILD
Number of MRI images that were used to assess for GLILD compared to High-resolution Computed Tomography (HRCT) use
Measured: 6 months
Infectious complications
Number of subjects to experience infectious complications
Measured: 6 months
Adverse Events
Number of adverse events reported
Measured: 6 months
Change in quality of life
Measured using the RAND 36-Short Form Survey Instrument (SF-36). The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability
Measured: Baseline, 6 months
Change in 6 minute walk test
Number of subjects to have a 10% improvement in 6 minute walk test. The 6 minute walk test measures the distance a person is able to walk in 6 minutes.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start12 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Variable ImmunodeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avni Joshi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Avni Joshi, Mayo Clinic
- Investigators
- Avni Joshi, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593588
- Sponsor's protocol ID
- 21-003119
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senolytics as a Novel Treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)
- ClinicalTrials.gov ID
- NCT05593588
- Acronym / sponsor ID
- 21-003119
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Avni JoshiUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fisetin Group | Experimental | Drug: FisetinSubjects will receive the supplement, Fisetin, for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29) |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must have received a diagnosis of CVID according to the international consensus document (ICON) at least 30 days before enrollment.
- Physician diagnosis of possible GLILD associated with CVID.
- IgA results.
- Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile. (A negative pregnancy test for women whose menopausal status is determined by self-reported absence of menstrual periods in the past 12 months will be required within 72 hours prior to randomization).
- Patient must be able and willing to comply with the requirements of this study protocol.
Key exclusion criteria (9 listed)
- Unable or unwilling to give informed consent.
- Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial.
- Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization.
- WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.
- Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fisetin20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29 | Drug | Fisetin Group |
| PlaceboLooks exactly like the study drug, but it contains no active ingredient. Administered orally on days 0, 1, 28 and 29 | Drug | Placebo Group |
Primary outcome
Change in immunophenotyping of peripheral T lymphocytes
Time frame: Baseline, 6 months
Measured by percentage of activated CD4+25+ T cells
7 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: Baseline, 6 months
Change in radiologic imaging in subjects
Time frame: Baseline, 3 months, 6 months
Use of MRI imaging for assessment of GLILD
Time frame: 6 months
Infectious complications
Time frame: 6 months
Adverse Events
Time frame: 6 months
Change in quality of life
Time frame: Baseline, 6 months
Change in 6 minute walk test
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avni Joshi, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fisetin in people with Common Variable Immunodeficiency and Interstitial Lung Disease Due to Systemic Disease, run by Avni Joshi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immunophenotyping of peripheral T lymphocytes (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.